Posted by Michael Wonder on 16 May 2017
Aerie Pharmaceuticals announces FDA acceptance of NDA submission for Rhopressa (netarsudil ophthalmic solution) 0.02%
15 May 2017 - PDUFA date set for 28 February 2018.
Aerie Pharmaceuticals today reported that it has received notification from the U.S. FDA that the FDA has completed its initial 60-day review of the Rhopressa new drug application and determined that the application is sufficiently complete to permit a substantive review.
The PDUFA goal date for the completion of the FDA's review of the Rhopressa application is set for February 28, 2018. This date reflects a standard 12-month review period and is consistent with management's expectations.
The notification also indicated that the FDA has not identified any potential review issues, and that the FDA is currently planning to hold an advisory committee.
